Luer lock fluid connectors are well known and often preferred for connecting tubing and medical equipment during many medical procedures. Capped fluid connectors are particularly preferred for many medical procedures, such as dialysis procedures, because they allow the sterility of the system to be maintained by the cap when the capped connector end is not attached to another piece of tubing or equipment. For instance, with the WHO.RTM. waste handling option for the CENTRY.RTM.3 dialysis apparatus manufactured by COBE.RTM. Laboratories, Inc., Lakewood, Colo., described in U.S. patent application Ser. No. 5,041,215 to Chamberlain, et al., capped fluid connectors are used with tubing sets for the dialysis unit. During set-up of the dialysis unit, the connector remains capped to maintain the sterility of the extracorporeal system. While the dialysis unit is expelling waste or being primed, the cap may be removed and the connector may be attached to the waste handling option or to a bag of sterile saline solution. Where the connector is capped with a breather cap, the cap may not have to be removed during priming or waste expelling. Of course, capped fluid connectors have many uses in medical treatment in addition to the described example.
It is often preferred for the manufacturer to pre-sterilize capped fluid connectors and ship the sterilized capped fluid connectors to the medical care provider for immediate use. Caps, therefore, should be applied to the connectors prior to sterilization. Manually capping fluid connectors prior to sterilization is labor intensive and, therefore, costly. It is less costly to apply the caps automatically, preferably in the same machine that manufactures the connector with a tethered cap.
Capped connectors are often manufactured by injection molding with separate caps attached to the connector by a flexible tether. In some prior art capped fluid connectors, the tether that attaches the cap to the connector is a flexible cord or leash. This design allows the cap to move in any direction and, therefore, does not facilitate automated capping. It is therefore, desirable to provide a capped luer fluid connector that is capable of being capped automatically, preferably in an injection molding machine.
Prior art capped fluid connectors may also have separate caps which may be automatically capped. Separate caps, however, are more expensive to manufacture because they require a separate mold. Furthermore, separate caps are easily lost when they are removed from the fluid connector.
Prior art capped fluid connectors are also available as a single piece having the cap hinged to an upper edge of the fluid connector. This design allows automated capping, however, it may not allow a threaded sleeve, some caps or the like to mate with the fluid connector because the hinge blocks the threaded sleeve or cap from engaging the corresponding threads on the exterior of the fluid connector.
U.S. Pat. No. 5,385,372 (1995) to Utterberg discloses a capped fluid connector where a rigid side arm maintains a hinged cap at a fixed distance from the connector's open end. The design of the Utterberg hinged cap requires that the rigid side arm hold the cap a fixed distance from the side of the connector, to allow sufficient space for the cap to cover the connector's open end. The rigid side arm is not movable and, therefore, maintains a constant space between the rigid side arm and connector wall. Therefore, the side arm cannot be moved out of the way when the connector is open and the cap is not being used. This design may not be compatible for use with various pieces of medical equipment, such as the WHO.RTM. waste handling option mentioned above, where the rigid side arm configuration would hinder or block attachment of the connector to the medical equipment. Further, because the cap is maintained rigidly in close proximity to the connector, there is the risk of manually contaminating the connector when the cap is manipulated.
It is desirable, therefore, to provide a capped fluid connector that may be molded as a single integral piece as well as capped automatically by the same injection molding machine. It is also desirable to provide a selectively rigid cap tether that holds the cap in a fixed position during automated capping but may be released to allow the cap and the tether to be moved out of the way when the connector is open and the cap is not being used. It is also desirable to provide a capped fluid connector that reduces the risk of accidental manual contamination. Against this background, the present invention was developed.